(61 days)
K/DEN number: Not Found
Not Found
No
The device description focuses on mechanical properties and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a surgical plate intended for fracture fixation and reconstructive surgery, which are structural and mechanical interventions, not typically classified as therapeutic in the sense of treating disease or providing ongoing therapy.
No
Explanation: The device description clearly states its purpose is for reconstructive surgery and fracture fixation, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable plate made of stainless steel or titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula." This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The description details a metal plate with screws designed for bone fixation. This is a physical implant, not a device used to examine samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Synthes 3.5mm Spring Plate does not fit this description.
N/A
Intended Use / Indications for Use
The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.
Product codes
HRS
Device Description
The Synthes 3.5mm Spring Plate is a variation of the Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, acetabular, distal fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes One-Third Tubular LCP Plates, with collar
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A horizontal line is present beneath the word, adding a sense of completion to the design. The overall impression is clean and professional.
SEP 1 2006
3.0 510(k) Summary
:
Page _________of _____________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6500 | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Device Name: | Synthes 3.5mm Spring Plate | | |
| Classification: | Class II, §888.3030 - Plate, Fixation, Bone (HRS) | | |
| Predicate Device: | Synthes One-Third Tubular LCP Plates, with collar | | |
| Device Description: | The Synthes 3.5mm Spring Plate is a variation of the Synthes
one-third tubular plate with collar which utilizes two sharp spikes
at the bottom surface and a pre-bent convex shape to aid in the
reduction of small bone fragments while conforming to bony
uneven surfaces. The plate incorporates a 1 - 10 hole design in
lengths ranging from 19.5mm - 132mm and accepts either 3.5mm
cortex or pelvic screws. In addition the plates are manufactured
from Stainless Steel and Commercially Pure Titanium and
provided STERILE and NON STERILE. | | |
| Intended Use: | The Synthes 3.5mm Spring Plate is intended for pelvic and
acetabular reconstructive surgery and fracture fixation of the distal
fibula. | | |
| Substantial
Equivalence: | Comparative information presented supports substantial
equivalence. | | |
:
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of an eagle, which is a common symbol of the United States. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2006
Synthes (USA) % Ms. Deborah Jackson Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K061973 Trade/Device Name: Synthes (USA) 3.5mm Spring Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 7, 2006 Received: July 12, 2006
Dear Ms. Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Deborah Jackson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Adubare Buelum
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word and logo.
ﺑ
| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K061973 |
|---|---|
| Device Name: | Synthes (USA) 3.5mm Spring Plate |
| Indications for Use: | The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula. |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Inelus
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number 406/973